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NPPV on Inflammatory Markers and Sleep in Severe Obese Patients With Metabolic Syndrome Undergone to Bariatric Surgery

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Вход / Регистрация
Линкът е запазен в клипборда
Състояние
Спонсори
Centro Universitário de Anapolis

Ключови думи

Резюме

Obesity is currently one of the most serious public health problems. Its prevalence is increasing sharply in recent decades, even in developing countries, leading to global epidemiology condition. Metabolic syndrome (MS) consists of an association of metabolic and cardiovascular disorders including central obesity, insulin resistance, dyslipidemia and hypertension in the same patient. Obstructive sleep apnea (OSA) is a common clinical condition in more than 60% patients with MS. It is still controversial in the world scientific literature whether treatment of OSA with Noninvasive Positive Pressure Ventilation (NPPV) in severely obese patients with and without MS is effective. The NPPV effectively reverses hypoxemia in patients with OSA, therefore justified the hypothesis that NPPV will reduce insulin resistance, ghrelin and resistin and raise adiponectin levels in a group of severely obese individuals with and without MS undergoing bariatric surgery. Objectives: To investigate the effects of Noninvasive Positive Pressure Ventilation on inflammatory markers, sleep, pulmonary function, BMI reduction and health related quality of life in severe obese patients with and without metabolic syndrome undergone to bariatric surgery.

Описание

Obesity is currently one of the most serious public health problems. Its prevalence is increasing sharply in recent decades, even in developing countries, leading to global epidemiology condition. Metabolic syndrome (MS) consists of an association of metabolic and cardiovascular disorders including central obesity, insulin resistance, dyslipidemia and hypertension in the same patient. Obstructive sleep apnea (OSA) is a common clinical condition in more than 60% patients with MS. It is still controversial in the world scientific literature whether treatment of OSA with Noninvasive Positive Pressure Ventilation (NPPV) in severely obese patients with and without MS is effective. The NPPV effectively reverses hypoxemia in patients with OSA, therefore justified the hypothesis that NPPV will reduce insulin resistance, ghrelin and resistin and raise adiponectin levels in a group of severely obese individuals with and without MS undergoing bariatric surgery. Objectives: To investigate the effects of Noninvasive Positive Pressure Ventilation on inflammatory markers, sleep, pulmonary function, BMI reduction and health related quality of life in severe obese patients with and without metabolic syndrome undergone to bariatric surgery. Methods/Design: Will participate severe obese patients with and without MS, screened from the Bariatric Surgery Service of Santa Casa de Sao Paulo. The inclusion criteria are patients with morbid obesity grade III, with an indication of bariatric surgery and who have agreed to the study, signing an informed consent. Subjects with BMI above 55 kg / m², clinically significant or mental health concerns unstable, an unrealistic target postsurgical weight and/or unrealistic expectations of the surgical treatment will be excluded. Patients will use the NPPV pre and post bariatric surgery. The evaluation protocol will consist of clinical history, vital signs, anthropometric data, clinical analysis of blood and adipose inflammatory markers, lung function tests, polysomnography, sleep scales, cardiovascular risk and quality of life questionnaires. Patients will be evaluated before and after bariatric surgery, 90, 180 and 360 days.

Дати

Последна проверка: 05/31/2018
Първо изпратено: 03/23/2015
Очаквано записване подадено: 04/02/2015
Първо публикувано: 04/05/2015
Изпратена последна актуализация: 06/12/2018
Последна актуализация публикувана: 06/14/2018
Действителна начална дата на проучването: 12/31/2014
Приблизителна дата на първично завършване: 04/30/2018
Очаквана дата на завършване на проучването: 06/30/2020

Състояние или заболяване

Metabolic Syndrome

Интервенция / лечение

Device: Noninvasive Ventilation and Surgery

Procedure: Noninvasive Ventilation and Surgery

Фаза

-

Групи за ръце

ArmИнтервенция / лечение
Experimental: Noninvasive Ventilation and Surgery
Noninvasive positive airway pressure flow generator device by full face or nasal mask and bariatric surgery.
Device: Noninvasive Ventilation and Surgery
Noninvasive positive airway pressure flow generator device.
No Intervention: Control Group

Критерии за допустимост

Възрасти, отговарящи на условията за проучване 18 Years Да се 18 Years
Полове, допустими за проучванеAll
Приема здрави доброволциДа
Критерии

Inclusion Criteria:

- male and female patients aged 18 to 65 years,

- grade III severe obesity (BMI ≥ 40 kg/m2) or ≥ 35 kg/m2 with comorbidities,

- awaiting bariatric surgery,

- with documented history of conventional weight loss attempts having proven unsuccessful over time,

- sleep apnea history verified through polysomnography

- and if they are able to understand and agreement to participate in the study through a signed term of informed consent.

Exclusion Criteria:

- Any medical condition rendering surgery too risky,

- BMI above 55 kg/m2,

- unrealistic postoperative target weight and/or unrealistic expectations of surgical treatment,

- pregnancy,

- lactation or planned pregnancy within two years of potential surgical treatment,

- lack of safe access to abdominal cavity or gastrointestinal tract;

- abusive alcohol use or drug use,

- craniofacial abnormalities,

- undergoing active treatment of sleep apnea,

- cancer,

- any cardiorespiratory condition opposite indicate the surgical procedure.

Резултат

Първични изходни мерки

1. Change in systemic immune response [Baseline immune response to 180 days.]

Systemic markers of inflammation through fasting blood samples biochemical indexes.

2. Change in systemic adipose inflammation response [Baseline adipose inflammation response to 180 days.]

Systemic markers of inflammation through biochemical indexes in visceral (omental, mesenteric) and subcutaneous adipose tissue depots.

Вторични изходни мерки

1. Prevalence of sleep disorders [180 days]

Study sleep patterns through full standard polysomnography.

2. Changes in pulmonary function [180 days]

Assess pulmonary function through pletysmography.

3. Changes in maximal ventilatory pressures [180 days]

Assess maximal inspiratory and expiratory pressures through manovacuometry.

4. Changes in health related quality of life [180 days]

Changes in quality of life through Short Form-36 and BAROS questionnaires.

5. Weight Loss [180 days]

Body mass index reduction.

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